A Study of PF-06873600 in People With Cancer
- Conditions
- Advanced solid tumor
- Registration Number
- JPRN-jRCT2031230326
- Lead Sponsor
- Kawai Norisuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 155
* Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer (prior combined CDK 4/6 inhibitor and endocrine therapy and 1 or 2 prior lines of chemotherapy)
* Have a diagnosis of metastatic triple negative breast cancer (TNBC) (up to 1-2 prior lines of chemotherapy)
* Have a diagnosis of advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) (up to 2-3 prior lines of therapy)
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
* Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1)
* Measurable disease as defined by RECIST 1.1 is required (Part 1B and Part 2 only)
* Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases
* Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
* Major surgery or radiation within 4 weeks prior to study entry
* Last anti-cancer treatment within 2 weeks prior to study entry
* Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
* Pregnant or breastfeeding female patients
* Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastro intestinal function or GI disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method * Number of patients with dose limiting toxicities in the Dose Escalation portion<br>* Safety and Tolerability as assessed by adverse event, safety laboratory abnormalities (hematology, chemistry, coagulation and urinalysis), vital signs and heart rate corrected QT interval)<br>* Objective Response Rate (ORR) observed in patients in the Dose Expansion Arms
- Secondary Outcome Measures
Name Time Method * PK parameter of PF-06873600<br>* ORR per RECIST version 1.1<br>* Time-to-event endpoint<br>* PD biomarkers (pRb and Ki67) in tumor tissue